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Lot4521_Stability_Protocol_v3.pdf↔ ELN
protocol exp_4521-Q1
v 3
Lot4521_HPLC_T0_run01.csv
raw T0
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Lot4521_HPLC_T0_run02.csv
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Lot4521_Dissolution_T0.xlsx
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Lot4521_chromatogram_peak3.tif
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streaming to Lot 4521 · Stability Q1 · seq 14 / 24
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streaming to Lot 4521 · Dissolution Profile · vessel 5 / 6
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streaming to Lot 4521 · QA Environmental Log · Day 14 / 365
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Q1 Stability Report
Arial 14 B I U
012345
Report Header
Q1 Stability Report — API-2025-03A · Lot 4521
Author: Dr. Jessica Martin · Site: Atlanta · Confidential
Body
Assay
98.4%
▲ within spec
Diss. T0
85%
▲ Q ≥ 80
Microbial
<10
▲ TVC pass
Assay % over Stability Timepoints Lot 4521 Spec ≥ 95
↪ data source: ELN · exp_4521-Q1 refreshed 2h ago
Sample ID Test Result Status
S-4521-T0 HPLC Assay 99.2% PASS
S-4521-M3 Dissolution Q=83% PASS
S-4521-M6 Impurities 0.18% REVIEW
ContinuousSection1 + Section
PROPERTIES
Chart1
DATA
Source ELN · exp_4521-Q1
Series Assay%
CHART
Type Line + area
Spec line ≥ 95%
LAYOUT
Size 6.5in, 2in